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Le test prénatal non invasif (TPNI) est une technique de dépistage prénatal qui ne présente pas de risque accru de fausse couche, peut être effectué plus tôt dans la grossesse et est plus précis que les technologies existantes. Cependant, ces avantages peuvent contribuer à l’érosion de l’autonomie reproductive. Entre 2013 et 2017, une étude intitulée PEGASE a été menée, validant les performances et l'utilité du TPNI, ainsi qu’analysant les implications économiques, éthiques, juridiques et sociales de la technologie. Le présent mémoire est basé sur les données d’une enquête auprès des professionnels de santé (N = 184). Ce mémoire aborde la relation entre les attitudes des professionnels de santé concernant a) le "consentement éclairé" et b) le "consentement écrit" dans le contexte du TPNI. Il remet en question le récit établi dans la littérature, que les professionnels qui croient que le consentement écrit pour le TPNI n'est pas important croient également que les procédures de consentement pour le TPNI «devraient devenir moins rigoureuses» (1). Les données montrent que ce sont les professionnels qui se soucient de l'autonomie qui doutent de l'importance du consentement écrit. Cela contredit le récit cité ci-dessus. Les opinions des professionnels sur le «consentement écrit» ne peuvent donc pas être utilisées pour inférer leurs opinions sur l’importance du «consentement éclairé». Il est recommandé d’enquêter les professionnels de la santé sur des considérations particulières liées à la pratique, telles que celles enquêtées dans cette étude, plutôt que d’interroger les répondants sur des concepts académiques tels le «consentement» ou l’«autonomie». / Non-Invasive Prenatal Testing (NIPT) is a new generation of prenatal screening that poses no increased risk of miscarriage, can be performed earlier in the pregnancy, and is more accurate than previously existing technologies. These advantages, however, potentially contribute to eroding reproductive autonomy, already under threat from other screening methods. Between 2013 and 2017, a study titled PEGASUS was conducted, validating the performance and utility of NIPT, as well as studying the economic, ethical, legal and social implications of the technology. One of these activities was a series of surveys conducted throughout Canada in 2015-16. The present thesis is based on the data from the healthcare professionals’ survey (N=184). This thesis addresses the relationship between healthcare professionals’ beliefs regarding a) “informed consent” and b) “written consent” in the context of NIPT. It questions the established narrative in the bioethics literature, that professionals who believe written consent for NIPT is not important also believe consent procedures for NIPT “should become less rigorous” than those used for invasive prenatal testing (1). Data from the survey shows that it is precisely those professionals who care about reproductive autonomy considerations who doubt the importance of written consent for NIPT. This directly contradicts the narrative cited above. Professionals’ stated views on “written consent” thus cannot be used to infer their unstated views on the importance of “informed consent”. It is recommended to investigate particular practice-based considerations such as the ones in this study rather than querying survey respondents on scholarly concepts such as “consent” or “autonomy”.

Ce mémoire de maîtrise tente de répondre à la question suivante : quelle est la valeur de l’autonomie dans le domaine de la recherche biomédicale, et plus particulièrement dans le contexte des biobanques? Pour éclairer cette question, nous étudierons le concept d’autonomie dans deux domaines d’éthique appliquée : l’éthique de la recherche et l’éthique de la santé publique. Depuis la deuxième moitié du XXe siècle, le respect de l’autonomie individuelle est un principe programmatique de l’éthique de la recherche. Or, sa conceptualisation a été accusée d’être trop individualiste pour répondre aux enjeux qui caractérisent la recherche en santé d’aujourd’hui. En éthique de la santé publique, au contraire, l’autonomie individuelle prend une place moins prépondérante et fait droit à des dimensions sociopolitiques de l’autonomie qui ont été négligées par le domaine de l’éthique de la recherche. Ces dimensions mettent en lumière le rôle des institutions dans la promotion de l’autonomie tout comme l’importance pour les individus d’avoir la possibilité de participer à l’élaboration des politiques de santé qui les concernent pour réaliser leur autonomie. Le cas de la recherche en contexte de biobanques sera l’occasion d’appliquer ces différentes conceptualisations de l’autonomie à un domaine de recherche en pleine expansion qui se situe au carrefour de l’éthique de la recherche et de l’éthique de la santé publique. / This master's thesis attempts to answer the following question: what is the value of autonomy in biomedical research, and more particularly in the context of biobanks? To answer this question, we will study the concept of autonomy in two areas of applied ethics: research ethics and public health ethics. Since the second half of the 20th century, respect for individual autonomy has been a programmatic principle of research ethics. However, many authors consider this conceptualization to be too individualistic to respond to the challenges that characterize health research today. In public health ethics, on the contrary, individual autonomy takes a less preponderant role and acknowledges some socio-political dimensions of autonomy that have been neglected by the field of research ethics. These dimensions highlight the role of institutions in promoting autonomy as well as the need for individuals to have the opportunity to participate in the development of health policies in order to achieve their autonomy. Finally, the case study of biobanks will provide an opportunity to apply these different conceptualizations of autonomy to a rapidly expanding field of research located at the crossroads between research ethics and public health.

Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.

[pt] O objetivo geral desta dissertação é verificar a possibilidade de aplicação de regime jurídico diverso ao proposto pelo Código Civil a situações jurídicas existenciais que envolvem a tomada de decisão das crianças e adolescentes, sobretudo àquelas que envolvem decisão sobre o próprio corpo. Para tanto, há três objetivos específicos a serem desenvolvidos. O primeiro deles é a apresentação da teoria da capacidade jurídica e os direitos fundamentais da personalidade para compreender a perspectiva de disposição jurídica de direitos fundamentais da personalidade. Em continuidade o segundo objetivo é investigar a dignidade da pessoa humana como autonomia para verificar a aplicação de teorias que sustentem a autonomia privada da criança e do adolescente em situações jurídicas existenciais. Por fim, o terceiro objetivo é discutir a capacidade de agir da criança e do adolescente em situações jurídicas existenciais a partir de três casos concretos. Como conclusão geral sustenta-se a aplicação da teoria realista da capacidade de agir, aproximando os conceitos de titularidade e legitimidade sempre que a criança e o adolescente reunirem os requisitos para serem sujeitos do consentimento, devendo ser observados os critérios de validade do consentimento. Concluiu-se ainda que a teoria realista da capacidade de agir deva ser aplicada para dar voz e dignidade aos menores quando envolverem situações jurídicas existenciais de efeitos reversíveis de sorte que esta última conclusão criou três zonas de aplicação da teoria de modo a graduá-la para respeitar o processo de desenvolvimento maturacional do menor e assegurar, assim, sua dignidade. / [en] The general objective of this dissertation is to verify the possibility of applying a different legal regime than the proposed by the Civil Code to existential legal situations involving decision making of children and adolescents, especially those that involve decision about their own body. To this end, there are three specific objectives to be developed. The first is the presentation of the theory of legal capacity and the fundamental rights of personality in order to understand the perspective of legal provision of fundamental rights of personality. The second objective is to investigate the human dignity as autonomy to verify the application of theories to support the private autonomy of the child and adolescent in existential legal situations. Finally, the third objective is to discuss the ability to act of children and adolescents in existential legal situations from three specific cases. As a general conclusion it is sustained the application of realist theory s ability to act, bringing together concepts of ownership and legitimacy when children and adolescents meet the requirements to be subject of consent, and that the criteria of validity of the consent must be observed. It was also concluded that the realist theory of capacity to act should be applied to give voice and dignity to children and adolescents when they involve existential legal situations of reversible effects. So that the latter conclusion has created three areas of application of the theory in order to upgrade it to respect the process of maturational development of children and adolescents and thus ensure their dignity.

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Background: The cluster randomized trial design randomly assigns groups of people to different treatment arms. This dissertation aimed to (1) develop machine learning algorithms to identify cluster trials in bibliographic databases, (2) assess reporting of methodological and ethical elements in hemodialysis-related cluster trials, and (3) assess how well two covariate-constrained randomization methods balanced baseline characteristics compared with simple randomization. Methods: In study 1, we developed three machine learning algorithms that classify whether a bibliographic citation is a CRT report or not. We only used the information available in an article citation, including the title, abstract, keywords, and subject headings. In study 2, we conducted a systematic review of CRTs in the hemodialysis setting to review the reporting of key methodological and ethical issues. We reviewed CRTs published in English between 2000 and 2019 and indexed in MEDLINE or EMBASE. In study 3, we assessed how well two covariate-constrained randomization methods balanced baseline characteristics compared with simple randomization. Results: In study 1, we successfully developed high-performance algorithms that identified whether a citation was a CRT. Our algorithms had greater than 97% sensitivity and 77% specificity in identifying CRTs. For study 2, we found suboptimal conduct and reporting of methodological issues of CRTs in the hemodialysis setting and incomplete reporting of key ethical issues. For study 3, where we randomized 72 clusters, constraining the randomization using historical information achieved a better balance on baseline characteristics than simple randomization; however, the magnitude of benefit was modest. Conclusions: This dissertation's results will help researchers quickly identify cluster trials in bibliographic databases (study 1) and inform the design and analyses of future Canadian trials conducted within the hemodialysis setting (study 2 & 3). / Thesis / Doctor of Philosophy (PhD) / The cluster trial design randomly assigns groups of people to different treatment arms rather than individuals. Cluster trials are commonly used in research areas such as education, public health, and health service research. Examples of clusters can include villages/communities, worksites, schools, hospitals, hospital wards, and physicians. This dissertation aimed to (1) develop machine learning algorithms to identify cluster trials in bibliographic databases, (2) assess reporting of methodological and ethical elements in hemodialysis-related cluster trials, and (3) identified best practices for randomly assigning hemodialysis centers in cluster trials. We conducted three studies to address these aims. The results of this dissertation will help researchers quickly identify cluster trials in bibliographic databases (study 1) and inform the design and analyses of future Canadian trials conducted within the hemodialysis setting (study 2 & 3).

1 Proxy decision making for incompetent patients Abstract The author of this thesis discusses the applicable Czech legislation on the proxy decision making for incompetent patients and the provision of medical care without informed consent. The thesis is divided into six parts, while the first part is devoted to the definition of the basic terms that are directly related to this topic and which are repeatedly used herein. These basic terms are the following: health services and healthcare, informed consent and the patient. The second chapter is devoted to sources of law, which are divided into three levels - international sources, European Union law and national sources. Within the national regulation, attention is focused mainly on Act No. 372/2011 Coll., On health services and conditions of their provision, as amended. It also outlines the issue of the duality of legal regulation, that was caused by the adoption of Act No. 89/2012 Coll., Civil Code. The third chapter deals with surrogate consent, attention is paid mainly to resolving conflicts of opinions and to the best interests pricniple, as to the key factor when granting the proxy consent. The fourth chapter is devoted to the institute of previously expressed wishes. The fifth chapter analyses the issue of providing health services to vulnerable...

Background: There has been tremendous progress in the use of genomics1 in biomedical research and medical care since the launch of the Human Genome Project in 1990. However, it has also introduced new ethical challenges regarding the feedback of findings generated in genomic sequencing. While some would argue in support of the return of individual findings generated from genomics research, participants' preferences regarding which findings should be fed back differs. Most literature discusses feedback of findings in high income countries and very few address this issue in lower and middle-income countries (LMICs). As a result, it remains unclear whether and how individual findings from genomic studies in Africa should be fed back, who should provide these results and when. Methods: In order to contribute to addressing this gap, an empirical study was conducted to explore expectations and preferences for feedback of individual genetic findings in an HIV-TB genomics research project in Botswana. A qualitative study methodology involving deliberative focus group discussions (dFGDs) and in-depth interviews (IDIs) was used. Participants for this study were adolescents involved in an HIV-TB genomics study being conducted at the Botswana-Baylor Children's Clinical Centre of Excellence (BBCCCE). Parents and caregivers of children enrolled in that same genomic study were also enrolled in this study. A total of 93 participants (44 adolescents and 49 parents and caregivers) were enrolled in 12 dFGDs (6 groups of adolescents and 6 groups of parents and caregivers). Each group of participants met twice within a week, resulting in a total of 24 dFGD meetings. Participants of the dFGDs and in-depth interviews were selected purposively. Additionally, indepth interviews were conducted with 12 dFGD participants (6 adolescents and 6 parents or caregivers). The dFGDs and IDIs were conducted in Setswana, audio-recorded, transcribed and translated into English. Data were imported into NVivo 12 and analysed using the framework approach for qualitative data analysis. Results: The study findings revealed that participants' desire to receive individual genetic results is underpinned by their cultural values, mainly solidarity and reciprocity. Participants viewed research participation as a mutual relationship and considered the return of research results to be one way of reciprocating their efforts. This seems to be underpinned by the principle of Ubuntu which advocates for solidarity and reciprocity within communities. Participants noted that when reciprocity obligations are respected, participants feel valued and expressed that not respecting reciprocity expectations could undermine participants' trust and participation in future studies. Almost all participants wanted to receive individual genetic results. While parents and caregivers wanted to receive individual genetic results regardless of their severity, preventability or actionability, adolescents were reluctant to receive results for genetic conditions that are severe and non-preventable, especially if they are also unactionable. Participants advanced different reasons for feedback of results including for awareness, improving lifestyle, accepting one's' situation, and preparing for the future. The findings also reveal the importance of taking into account participants' context, relations and empowerment when making decisions about whether and which results ought to be fed back. When asked about practical considerations for feedback of results, both adolescents and parents expressed that they would prefer to receive individual genetic results in person, with adolescents preferring researchers to provide feedback, while parents preferred feedback from doctors associated with the study. Adolescents and parents both expressed that feedback should be supported by counselling, but they differed on the timing of feedback. Most participants shared that they would like to be informed about the possibility of discovering individual genetic results during the consent process and that consent be obtained for feedback during the enrolment process. They further expressed that in cases where prior consent to feedback was not obtained, then participants should be re-contacted where lifesaving genetic information is discovered. Participants emphasized the need for researchers to ensure that participants' decisions regarding feedback of results are well-informed. Autonomy, transparency, and communication were identified as key values to uphold during the consent process. Conclusion: In conclusion, expectations of solidarity and reciprocity could translate into an obligation to feedback selected individual genetic results in African genomics research. Decisions on practicalities for feedback of results should take into account participants' context and considerations of participants' preferences. For example, in settings like BBCCCE it might be feasible for the study team to relay participants' results to treating doctors in the same centre, while also organising counselling services if necessary. However, in cases where a study is done in a public facility with limited resources, that could be difficult to implement. Consequently, researchers may have to take up the responsibility of feeding back individual results as well as providing genetic counselling in such settings. To make these decisions, researchers should engage with relevant stakeholders including policymakers and local Institutional Review Boards (IRBs) so as to make informed decisions regarding the feasibility and acceptability of their approach to feedback of results. Obtaining participants' consent for feedback of results is important to ensure that their rights and wellbeing are protected in research. This is critical in building trust relationships between participants and researchers. Lastly, although this study is focused in Botswana, these findings could also be generalised to similar contexts in Africa and provide an authoritative voice to H3Africa to be able to mandate projects with potential to generate individual genetic results to make provisions to feedback these results to study participants.